The Recall Desk
HighFDA (Devices)·Z-0026-2018·Announced 2017-10-25

CareFusion Recalls Alaris Pump Modules Due to Flow Rate Variations

CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of increased or decreased medication flows.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a functional defect (flow rate variation) that poses a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units manufactured between November 2011 and March 2012. The recall also includes Alaris Pump Modules serviced with specific LVP Mechanism Sub Assemblies or Bezel Kit Assemblies during the same period. The Alaris Pump module is a large volume infusion pump used to deliver medication and fluids via IV administration sets.

The recall was initiated after the firm received reports of increased or decreased flows occurring in certain pumps. This defect could affect the accuracy of medication delivery through clinically acceptable routes such as intravenous or epidural administration.

A total of 31,622 units are affected, with 28,224 units distributed in the United States. The products were distributed nationwide in the US and to Canada, Australia, UAE, Kuwait, Saudi Arabia, and South Africa. Healthcare facilities should identify affected units by checking serial numbers and contact CareFusion for instructions on corrective action.

The recalled product

Product
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 201
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Infusion Pump
Hazard

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · CareFusion 303, Inc.

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